Valneva SE (VALN) , a specialty vaccine company, has achieved a significant milestone with the approval of its single-dose chikungunya vaccine, IXCHIQ, by Health Canada. This approval follows the FDA's nod in November 2023 as well as the European Medicines Agency's recent recommendation for marketing authorization in Europe.This latest endorsement positions Valneva to significantly impact the chikungunya vaccine market globally.A Few Words on ChikungunyaAlso known as CHIKV, Chikungunya is a mosquito-borne v ...

Saint-Herblain (France), June 24, 2024 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that Health Canada has approved IXCHIQ®, Valneva's single-dose vaccine for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. This decision marks the second approval the Company has received for IXCHIQ® following approval from the U.S. Food and Drug Administration (FDA) in November 2023. The European Medicines Agency (EMA) also recently r ...

文章核心观点 - 加拿大卫生部批准了Valneva公司的单剂量基于活性减毒的IXCHIQ®疫苗,用于预防18岁及以上人群感染基孔肯雅病毒引起的疾病 [1] - 这是IXCHIQ®疫苗继美国FDA批准后获得的第二个批准,欧洲药品管理局也已经建议批准该疫苗 [1] - IXCHIQ®是目前世界上唯一获批的基孔肯雅疫苗,可以解决这一未满足的医疗需求 [1] 行业概况 - 每年有超过5000万北美人,其中约700万加拿大人1前往基孔肯雅病毒流行地区旅行 [2] - 气候变化导致传播基孔肯雅和登革热病毒的白纹伊蚊扩散到之前未受影响的地区,基孔肯雅疫情规模和频率正在加速增加 [5] - 仅在2023年,美洲、南亚和非洲就已报告了数十万例基孔肯雅病例 [5] - 基孔肯雅病毒感染造成的医疗和经济负担预计会随着气候变化而不断加重,世界卫生组织将其列为重大公共卫生问题 [6] 公司概况 - 公司专注于开发、生产和销售预防性疫苗,针对未满足的医疗需求采取高度专业和针对性的方法 [7][8] - 公司已成功推出多款自有和第三方疫苗,包括世界上第一个也是唯一获批的基孔肯雅疫苗 [8] - 公司正在开发针对莱姆病、寨卡病毒等的疫苗候选药物,以及其他针对全球公共卫生威胁的疫苗 [9]

Saint-Herblain (France), June 5, 2024 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company ("the Company"), today announced the availability of documentation for its Combined General Meeting ("the Meeting") to be held on June 26, 2024 at 2:00 p.m. CEST at the Sofitel Lyon Bellecour Hotel, 20 quai du Docteur Gailleton, 69002 Lyon (France). The Preliminary Notice of Meeting – including the agenda, the draft resolutions proposed by the Board of Directors, and instructions for participation and vo ...

Saint-Herblain (France), June 4, 2024 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that management will participate at several upcoming investor conferences in the United States and Europe during June 2024. Valneva will present and meet with global institutional investors to discuss VLA15, the world's leading Lyme Disease vaccine candidate, in Phase 3 development and partnered with Pfizer; the Company's growing commercial business, including ongoing launch plans for IX ...

Saint-Herblain (France), June 4, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that management will participate at several upcoming investor conferences in the United States and Europe during June 2024. Valneva will present and meet with global institutional investors to discuss VLA15, the world’s leading Lyme Disease vaccine candidate, in Phase 3 development and partnered with Pfizer; the Company’s growing commercial business, including ongoing launch p ...

Saint-Herblain (France), June 3, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the results of two Phase 2 clinical trials of Lyme disease vaccine candidate, VLA15, were published in the peer-reviewed medical journal, The Lancet Infectious Diseases. These trials, as well as a third Phase 2 trial in pediatric participants, supported the design of the current pivotal Phase 3 trial, 'Vaccine Against Lyme for Outdoor Recreationists' (VALOR). Juan Carlos ...

Saint-Herblain (France), June 3, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the results of two Phase 2 clinical trials of Lyme disease vaccine candidate, VLA15, were published in the peer-reviewed medical journal, The Lancet Infectious Diseases. These trials, as well as a third Phase 2 trial in pediatric participants, supported the design of the current pivotal Phase 3 trial, 'Vaccine Against Lyme for Outdoor Recreationists' (VALOR). Juan Carlos ...

If approved, IXCHIQ® will become the first vaccine available in the EU against the chikungunya virus (CHIKV)Decision on EU marketing authorization expected in the third quarter of 2024 Saint Herblain (France), May 31, 2024 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending authorization of Valneva's single-dose vaccine for the prev ...

Valneva SE (NASDAQ:VALN) Q1 2024 Earnings Conference Call May 7, 2024 9:00 AM ET Company Participants Josh Drumm - VP, Global Investor Relations Thomas Lingelbach - President, CEO & Director Peter Buhler - CFO Conference Call Participants Max Herrmann - Stifel Rajan Sharma - Goldman Sachs Evan Wang - Guggenheim Samir Devani - RX Securities Limited Ed White - H.C. Wainwright & Co. Suzanne van Voorthuizen - Van Lanschot Kempen Maury Raycroft - Jefferies Josh Drumm Hello, and thank you for joining us to discu ...